Over 2.4M burn injuries are reported in the United States each year and burns represent one of the most expensive catastrophic injuries to treat. Burn and associated scar injury have both functional and emotional (aesthetic) impact on patients. The current medical standard of care for thermal burn injury targets pain relief (analgesics and NSAIDs) and prevention of infection (topical antibiotics). This invention describes a topical therapeutic intervention that reduces the severity of thermal burn injury as well as burn-induced scar formation. Limiting scar formation has applications for traumatic or surgical induced scar formation as well as scars have both physical (functional) and emotional (aesthetic) impact on patients.
Natural vitamin E exists in two forms: tocopherols and tocotrienols. Both tocopherols and tocotrienols possess a chromanol ring, and within families the isoforms are differentiated as a, β, γ, and δ according to the presence of methyl groups at positions 5, 7, and 8, respectively. Tocopherols are characterized by a saturated side chain, whereas tocotrienols possess an isoprenoid side chain with double bonds at C-3, -7 and -11.
Clinical trials testing the effects of vitamin E in a wide range of major health disorders have come to the general conclusion that vitamin E either is not helpful or could be harmful under certain conditions. Meta-analyses of over 20 randomized, controlled clinical trials testing vitamin E have now reached conclusions that on one hand serve the basis for readjusting public policies and practices while on the other suffer from a major blind spot which is not recognized in any of these reports. While title claims of such meta-analyses address vitamin E as whole, they fail to recognize that the form of vitamin E studied in the vast majority of these trials is α-tocopherol which represents one-eighth of the natural vitamin E family.
Palm oil represents a major source of natural tocotrienol. Tocotrienol possess powerful neuroprotective, antioxidant, anti-cancer and cholesterol lowering properties that often differ from the properties of tocopherol. Micromolar amounts of tocotrienol suppress the activity of HMG-CoA reductase, the hepatic enzyme responsible for cholesterol synthesis. Tocotrienols are thought to have more potent antioxidant properties than tocopherol. The unsaturated side chain of tocotrienol allows for more efficient penetration into tissues that have saturated fatty layers such as the brain and liver. Comparative examination of the antioxidant properties of tocopherol and tocotrienol revealed that tocotrienol is advantageous because of their better distribution in the fatty layers of the cell membrane. Recently, an antiangiogenic function of tocotrienol has been reported. Like tocopherol, tocotrienols have been identified to possess distinct functions that may benefit human health, yet tocotrienol accounts for a very small fraction of overall vitamin E research.
Vitamin E: Basic Information
Vitamin E is a fat-soluble vitamin that exists in eight different forms. Each form has its own biological activity, which is the measure of potency or functional use in the body. Vitamin E is a dietary antioxidant that assists in maintaining cell integrity. It is obtained from sunflower, safflower, canola, and olive oils; also from many grains, nuts, fruits as well as fatty parts of meats. The tocotrienol form of natural vitamin E is found in rice and cereals but more abundantly in palm oil. Palm oil is an integral part of daily diet in southeastern Asia.
Only a small amount of vitamin E is needed to meet normal daily requirements. However, research using vitamin E at higher doses than the daily requirement has provided preliminary evidence that it may be helpful for preventing or treating various medical conditions. These uses include treating menstrual pain, cardiac autonomic neuropathy (a complication of diabetes), low sperm count, restless leg syndrome, inflammation of eye tissues, Alzheimer's, Parkinson's and rheumatoid arthritis. Vitamin E also might improve seniors' immune response. Studies show that for people already at high risk for heart disease or with a prior history of the condition, vitamin E may not be helpful. Vitamin E also once was considered a promising treatment for preventing several kinds of cancer. However, current evidence points only to the prevention of prostate cancer.
Natural vitamin E is biologically active. This study involves supplementation of natural vitamin E Synthetic vitamin E (sometimes referred to as dl-alpha-tocopherol) is only half as active as the natural form of vitamin E.
Vitamin E: Safety
To date, there have been no related adverse affects in the inventors' current IRB protocol (200500034). In this protocol, patients are being supplemented 200 mg TCT twice a day for a minimum of 4 weeks prior to surgery. The maximum supplementation has been for over a year (currently on-going supplementation)
Vitamin E 20% cream (tocotrienol cream) has no known toxic effect because the cream is applied topically and systemic absorption is negligible.
Vitamin E is a commonly used, safe nutrient that is required to ensure general health. A recent analysis of data from several clinical trials suggests that excessive vitamin E may raise the risk of death slightly in older individuals with existing medical conditions. Excessive vitamin E may cause bleeding problems resulting in hemorrhaging. The Food and Nutrition Board of the Institute of Medicine has set an upper tolerable intake level (UL) for vitamin E at 1,000 mg (1,500 IU) for any form of supplementary alpha-tocopherol per day. Based, for the most part, on the result of animal studies, the Board decided that because vitamin E can act as an anticoagulant and may increase the risk of bleeding problems, this UL is the highest dose unlikely to result in bleeding problems.